Open AccessDownstream bioprocessing of human pluripotent stem cell‐derived therapeutics
Author(s) -
Sart Sebastien,
Liu Chang,
Zeng Eric Z.,
Xu Chunhui,
Li Yan
Publication year - 2022
Publication title -
engineering in life sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.547
H-Index - 57
eISSN - 1618-2863
pISSN - 1618-0240
DOI - 10.1002/elsc.202100042
Subject(s) - bioprocess , downstream (manufacturing) , downstream processing , induced pluripotent stem cell , human induced pluripotent stem cells , microbiology and biotechnology , computational biology , biochemical engineering , chemistry , biology , embryonic stem cell , engineering , biochemistry , operations management , paleontology , gene
With the advancement in lineage‐specific differentiation from human pluripotent stem cells (hPSCs), downstream cell separation has now become a critical step to produce hPSC‐derived products. Since differentiation procedures usually result in a heterogeneous cell population, cell separation needs to be performed either to enrich the desired cell population or remove the undesired cell population. This article summarizes recent advances in separation processes for hPSC‐derived cells, including the standard separation technologies, such as magnetic‐activated cell sorting, as well as the novel separation strategies, such as those based on adhesion strength and metabolic flux. Specifically, the downstream bioprocessing flow and the identification of surface markers for various cell lineages are discussed. While challenges remain for large‐scale downstream bioprocessing of hPSC‐derived cells, the rational quality‐by‐design approach should be implemented to enhance the understanding of the relationship between process and the product and to ensure the safety of the produced cells.